Objectives: Follitropins of both human and recombinant origins are well established as safe and effective therapy for oligoanovulatory infertile patients desiring pregnancy. Ferring hFSH (FhFSH)™ is a new, highly purified human follitropin. The objectives of the present study were to determine the efficacy and safety of FhFSH™ administered subcutaneously (SC) and intramuscularly (IM) compared to the recombinant FSH (rFSH), Follistim administered SC in oligoanovulatory patients for ovulation induction.Design: Open-label, randomized, parallel-group, multi-center study.Materials and Methods: After screening, each eligible patient was down-regulated with daily injections of leuprolide acetate 0.5 mg SC up to 20 days commencing on day 2 of menses until serum E2 was 45 pg/mL and the endometrial lining was <6 mm on transvaginal ultrasound. One hundred eleven (111) patients were randomly assigned to receive FhFSH™ SC or IM or Follistim® SC as a single daily dose of 150 IU for 5 days, after which doses were individualized to a maximum of 450 IU qd for a total duration not exceeding 12 days. At least one follicle ≥14 mm in diameter on ultrasound with appropriate E2 levels was required to receive human chorionic gonadotropin (hCG) 10,000 USP units IM on the day after the last dose of follitropin.Results: The primary efficacy variable was the percentage of patients achieving ovulation defined as progesterone (P4) values ≥10 ng/mL from 6 to 9 days post hCG administration, based on an intent-to-treat analysis of all randomized patients. Key secondary efficacy variables included peak E2 levels, the percentage of patients receiving hCG and achieving pregnancy (chemical, clinical, and continuing). There were no statistically significant differences among the treatment groups for ovulation or key secondary variables. The following table summarizes these results. Tabled 1Efficacy variables–intent to treatParameterFhFSH™ SCFhFSH™ IMrFSH SCP valuen = 36n = 37n = 38Ovulation (%)25 (69.4)26 (70.3)30 (78.9)0.591Received hCG (%)26 (72.2)28 (75.7)35 (92.1)0.071Peak serum estradiol pg/mL (SD)990.9 (676.2)893.2 (815.2)1,109.0 (788.9)0.474Pts. with chemical pregnancy (%)11 (30.6)8 (21.6)13 (34.2)0.466Pts. with clinical pregnancy (%)9 (25.0)7 (18.9)11 (28.9)0.595Pts. with continuing pregnancy (%)9 (25.0)7 (18.9)10 (26.3)0.724 Open table in a new tab All three treatments were safe and well tolerated.Conclusions: FhFSH™ SC and IM is as safe and effective as Follistim® SC for ovulation induction in oligoanovulatory infertile patients. Objectives: Follitropins of both human and recombinant origins are well established as safe and effective therapy for oligoanovulatory infertile patients desiring pregnancy. Ferring hFSH (FhFSH)™ is a new, highly purified human follitropin. The objectives of the present study were to determine the efficacy and safety of FhFSH™ administered subcutaneously (SC) and intramuscularly (IM) compared to the recombinant FSH (rFSH), Follistim administered SC in oligoanovulatory patients for ovulation induction. Design: Open-label, randomized, parallel-group, multi-center study. Materials and Methods: After screening, each eligible patient was down-regulated with daily injections of leuprolide acetate 0.5 mg SC up to 20 days commencing on day 2 of menses until serum E2 was 45 pg/mL and the endometrial lining was <6 mm on transvaginal ultrasound. One hundred eleven (111) patients were randomly assigned to receive FhFSH™ SC or IM or Follistim® SC as a single daily dose of 150 IU for 5 days, after which doses were individualized to a maximum of 450 IU qd for a total duration not exceeding 12 days. At least one follicle ≥14 mm in diameter on ultrasound with appropriate E2 levels was required to receive human chorionic gonadotropin (hCG) 10,000 USP units IM on the day after the last dose of follitropin. Results: The primary efficacy variable was the percentage of patients achieving ovulation defined as progesterone (P4) values ≥10 ng/mL from 6 to 9 days post hCG administration, based on an intent-to-treat analysis of all randomized patients. Key secondary efficacy variables included peak E2 levels, the percentage of patients receiving hCG and achieving pregnancy (chemical, clinical, and continuing). There were no statistically significant differences among the treatment groups for ovulation or key secondary variables. The following table summarizes these results. Tabled 1Efficacy variables–intent to treatParameterFhFSH™ SCFhFSH™ IMrFSH SCP valuen = 36n = 37n = 38Ovulation (%)25 (69.4)26 (70.3)30 (78.9)0.591Received hCG (%)26 (72.2)28 (75.7)35 (92.1)0.071Peak serum estradiol pg/mL (SD)990.9 (676.2)893.2 (815.2)1,109.0 (788.9)0.474Pts. with chemical pregnancy (%)11 (30.6)8 (21.6)13 (34.2)0.466Pts. with clinical pregnancy (%)9 (25.0)7 (18.9)11 (28.9)0.595Pts. with continuing pregnancy (%)9 (25.0)7 (18.9)10 (26.3)0.724 Open table in a new tab All three treatments were safe and well tolerated. Conclusions: FhFSH™ SC and IM is as safe and effective as Follistim® SC for ovulation induction in oligoanovulatory infertile patients.